Kornimate/medical-research-clean huggingface dataset:
registry of first-line treatments in patients with critical limb ischemia

Conditions: Critical Limb Ischemia

Summary: the principal research question is which treatment modality between open surgical, endovascular and conservative therapy is the most effective in terms of limb salvage, survival and reinterventions in patients with critical limb ischemia

the target population consists of patients suffering from critical limb ischemia (cli) lasting more than 2 weeks. cli is defined as rest pain or tissue loss (fontaine stages iii-iv or rutherford classes 4 to 6) and/or ankle-brachial index \< 0.40. patient with acute limb-threatening ischemia, bone fractures in the relevant areas, nonatherosclerotic disease (e.g. arteriitis) and documented hypercoagulable diseases will be excluded from this study. there will be no experimental or control groups. the comparison groups will be: group 1: best endovascular treatment (angioplasty +/- stent) group 2: best surgical treatment \[bypass (vein or prosthetic)\] group 3: femoral artery patchplasty +/- profundoplasty (+/- endovascular treatment) group 4: best conservative treatment the proposed sample size amounts to 1200 patients. to be assessed for eligibility (n=1200) to be allocated to trial (n=1000) to be analysed (n=900) in critisch registry, randomization or blinding is not feasible, because optimized standard care will be performed as established at each participating centre (best medical treatment). data storage, validation, monitoring, update, backup and analysis will be performed centrally following established procedures. web-based software will be used to develop a data model representing the data structure. the data validation will include standard data validation techniques such as the manual review of selected variables and the routine check of missing and outlying data points. regional staff will be instructed and supervised by study nurse, who will perform the study monitoring. assessment of relevant prognostic factors during the statistical analysis will prevent biased results due to the non-randomized design and the potential structural inequality.

Eligibility criteria:
inclusion criteria: * rest pain or tissue loss (fontaine stages iii-iv or rutherford classes 4 to 6) and/or ankle-brachial index \< 0.40 exclusion criteria: * acute limb-threatening ischemia * bone fractures in the relevant areas * non-atherosclerotic disease (e.g. arteriitis) * documented hypercoagulable diseases

Keywords: critical limb ischemia endovascular treatment open surgical repair diabetic foot
efficacy of peripheral magnetic stimulation to reduce pain in knee osteoarthritis.

Conditions: Osteoarthritis of Knee

Summary: to investigate effects of repetitive peripheral magnetic stimulation (pms) on pain reduction in knee osteoarthritis


Eligibility criteria:
inclusion criteria: * primary knee osteoarthritis patients who have had knee pain for at least 6 months and age more than 50 years, had morning stiffness not more than 30 minutes or crepitation. * kellgren and lawrence classification 2-4 * visual analog scale of pain 4 or higher. exclusion criteria: * patients with other musculoskeletal problems associated with knee joint * patient with history of physical therapy in past 1 month * patient with pacemaker, cochlear implant or cerebral shunt * patient with history of knee surgery * patient with neurological or other severe disease * patient with previous seizure.
drug use surveillance of vonoprazan for "gastric ulcer, duodenal ulcer, and reflux esophagitis"

Conditions: Gastric Ulcer, Duodenal Ulcer, and Reflux Esophagitis

Summary: the purpose of this survey is to evaluate the safety and effectiveness of vonoprazan tablets in patients with gastric ulcer, duodenal ulcer, and reflux esophagitis in the routine clinical setting.

the drug being tested in this survey is called vonoprazan. vonoprazan is being tested to treat patients who have gastric ulcer, duodenal ulcer, and reflux esophagitis. this survey will look at the safety and effectiveness of vonoprazan in patients with gastric ulcer, duodenal ulcer, and reflux esophagitis in the routine clinical setting. the survey will enroll approximately 3000 participants. - vonoprazan 20 mg this multi-center survey will be conducted in japan.

Eligibility criteria:
inclusion criteria: - participants with gastric ulcer, duodenal ulcer, and reflux esophagitis exclusion criteria: * participants with previous history of hypersensitivity to ingredients in takecab tablets * participants taking atazanavir sulfate or rilpivirine hydrochloride * participants meeting the criteria of scarring stage (s1, s2) of endoscopic classification defined by sakita and miwa at the start of the treatment with takecab tablets, in the case that the target disease is gastric ulcer or duodenal ulcer * participants meeting the criteria of grade n or grade m of los angeles classification (hoshihara's modification) at the start of the treatment with takecab tablets, in the case that the target disease is reflux esophagitis.
three dosing regimens of dextromethorphan (dxm) reportedly used in major depressive disorder

Conditions: MDD; Treatment Resistant Depression; Smoking Cessation; Smoking

Summary: this is an open-label dosing pilot study of 15 patients aged 18-50 years of age with diagnoses of major depressive disorder (mdd) randomized to 1 of 3 treatment arms. the study will consist of a screening evaluation performed within the course of 2 weeks, followed by an active treatment period of 28 days where treatment arm 1 will take a supervised dose of 300mg dxm every 14 days for 28 days, treatment arm 2 will take the fda approved maximum daily ingestion for cough (60mg dxm) daily for 28 days, and treatment arm 3 will take 1 supervised dose of 300mg dxm and 60mg for the remaining 28 days. after the active treatment period, subjects will be followed for 65 days with safety and psychiatric assessments at designated timepoints.


Eligibility criteria:
inclusion criteria: * subject must be a man or woman, 18 to 50 years, inclusive * subject must meet diagnostic and statistical manual of mental disorders 5th edition (dsm-v) criteria for mdd without psychotic features based on clinician assessment. * subjects must have undergone 3 or fewer antidepressant trials * subjects must have moderate to severe depression as determined by a screening montgomery-åsberg depression rating scale (madrs) score of 20 or greater exclusion criteria: * subject has a current diagnosis of bipolar affective spectrum disorder, obsessive compulsive disorder, or a dsm-v personality disorder * subject has had an incomplete response to more than 3 antidepressant trials * subject cannot tolerate 60mg dxm as determined by study physician * subject meets dsm-5 severity criteria for moderate or severe substance or alcohol use disorder within 6 months of screening, excluding caffeine or nicotine * subject has a current clinical diagnosis of autism, dementia, or intellectual disability * subject has history of psychosis not attributable to organic/metabolic causes * subject has a history of serotonin syndrome or sensitivity * subject has taken venlafaxine or a monoamine oxidase inhibitor (maoi) within 4 weeks prior to screening * subject is actively taking an opiate antagonist for any indication * subject is taking a higher-than-recommended dosage of serotonergic antidepressant \[including but not limited to selective serotonin reuptake inhibitor (ssri), serotonin-norepinephrine reuptake inhibitor (snri), serotonin partial agonist/reuptake inhibitor (spari), serotonin antagonist and reuptake inhibitor (sari) within 4 weeks prior to screening * subject is actively suicidal * subject has participated in another clinical drug trial within 6 months prior to screening * subject has a history or current signs of liver or renal insufficiency * subject has a clinically significant condition of any organ system that might adversely impact subject health upon consumption of dxm * subject has previous history of intolerance to ketamine or its enantiomers * subject has previous history of incomplete antidepressant response to ketamine or its enantiomers * subject is currently using dxm for any indication
dna methylation and urothelial carcinoma

Conditions: Urothelial Carcinoma

Summary: many studies previously showed the significant association between urinary arsenic profiles and urothelial carcinoma (uc) risk and observed the increased uc risk in people with lower plasma folate and higher homocysteine than those with higher plasma folate and lower homocysteine. the investigators would expect to explore the interactions among global dna methylation, one-carbon metabolic pathway factors, urinary arsenic profiles and uc.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of urothelial carcinoma * the voluntary of participating the study exclusion criteria: * age smaller than 20 years * pregnant women * not willing to participate the study because of their personal reasons
the effects of the safe and sound protocol on ptsd symptoms and anxiety

Conditions: Post Traumatic Stress Disorder; Anxiety

Summary: the safe and sound protocol (ssp) is a passive acoustic intervention that is designed as a "neural exercise" to promote efficient regulation of autonomic state. prior research has shown that the ssp can improve autonomic function, auditory hypersensitivities, and emotion regulation in individuals with autism spectrum disorders. this observational pilot study is being conducted to establish methods for an upcoming randomized controlled trial to test the utility of the ssp for trauma treatment. this study will enroll clients at the spencer psychology clinic who are set to take part in ssp under the supervision of their therapist. because the therapists have participated in the design of the protocol and will participate in data collection and analysis, ssp will be considered a research procedure. in addition to taking part in ssp, subjects complete a set of questionnaires and have their pulse measured before starting the ssp intervention, after having completed 2/5 hours of the ssp, one week after completing all 5 hours of the ssp, and one month after completing the ssp intervention. the investigators will also pull relevant information from spencer psychology's medical records to document diagnosis, track client progress during study, and augment self-reported demographics. clients who are receiving psychotherapy but not the ssp will be recruited as a comparison group.


Eligibility criteria:
ssp intervention arm: inclusion criteria: * client at spencer psychology in bloomington, indiana * diagnosed with ptsd or trauma not otherwise specified * already have agreed with therapist to administer ssp as a part of therapy exclusion criteria: * tinnitus or hearing loss * diagnosed with cardiac arrhythmia * at high risk for 2019 novel coronavirus (covid-19) complications based on center for disease control (cdc) guidelines, unless vaccinated comparison (treatment as usual) arm additional criteria: inclusion criteria: 1. 18 years of age or older 2. active psychotherapy client at spencer psychology 3. diagnosis of ptsd or trauma not otherwise specified 4. match range of pcl-5 baseline scores with treatment arm during screener survey exclusion criteria: 1. currently using or have previously used the safe and sound protocol (ssp) in therapy 2. current therapy includes eye movement desensitization and reprocessing (emdr)

Keywords: post traumatic stress disorder anxiety ptsd treatment safe and sound protocol ssp auditory intervention music intervention
researching cardiovascular events with a weekly incretin in diabetes (rewind)

Conditions: Cardiovascular Disease; Diabetes Mellitus, Type 2

Summary: the purpose of this trial is to assess whether dulaglutide can reduce major cardiovascular events and other serious outcomes in persons with type 2 diabetes, when added to their anti-hyperglycemic regimen.


Eligibility criteria:
inclusion criteria: * type 2 diabetes with hemoglobin a1c equal to or less than 9.5% (equal to or less than 81 mmol/mol) * anti-hyperglycemic drug naive or treated with up to 2 oral hyperglycemic drugs with or without a glucagon-like peptide-1analog or basal insulin, or basal insulin alone * on stable antihyperglycemic regimen for at least 3 months * age equal to or greater than 50 years with established clinical vascular disease, or age equal to or greater than 55 years and subclinical vascular disease or age equal to or greater than 60 years and at least 2 or more cardiovascular risk factors exclusion criteria: * uncontrolled diabetes requiring immediate therapy * history of severe hypoglycemia in past year * acute coronary or cerebrovascular event within past 2 months * planned or anticipated revascularization procedure * history of pancreatitis, hepatic insufficiency , chronic renal failure or of c-cell thyroid disorder * pregnancy or planned pregnancy during the trial period * completed or withdrawn from any study investigating dulaglutide

Keywords: cardiovascular disease diabetes mellitus dulaglutide
pharmacokinetics of resveratrol comprising products

Conditions: Healthy

Summary: this study was designed to assess the pharmacokinetics of 2 doses of red grape cells (rgc) containing resveratrol compared with a reference. rgc will be administered as single oral dose to fasting healthy volunteers. plasma concentration of free resveratrol and total conjugates will be analyzed.


Eligibility criteria:
inclusion criteria: * ages 18-55 years; * bmi \>/= 19 and \</= 30 * non smoking * without history or evidence of significant cardiovascular, hepatic, renal, respiratory, gastrointestinal disease * normal physical and laboratory examinations exclusion criteria: * history or evidence of alcohol or drug abuse * subjects receiving chronic medication * unusual dietary habits or a recent change in body weight * acute medical situation 48 hours prior to initiation of the study * poor venous access * subjects participated in a trial or donated blood within 4 weeks before initiation of the study
treatment of post-surgical cystoid macular edema with topical steroids trial (tempest-1)

Conditions: Post-surgical Cystoid Macular Edema (PSCME)

Summary: the purpose of this study is to compare the change in visual acuity of patients with post surgical cystoid macular edema who will be treated with two different regimens.

compare the mean change in bcva over 12 weeks of prednisolone acetate 1% q1h (every hour) wa (while awake) + ketorolac 0.5% qid (four times a day) versus prednisolone acetate qid + ketorolac qid for post surgical cystoid macular edema.

Eligibility criteria:
inclusion criteria: * age more than or equal to 18 years * diagnosis of pscme in study eye confirmed by fa showing leakage from retinal vessels resulting in pooling of dye in the fovea and spectralis sd-oct showing intraretinal fluid in or around the fovea. * bcva score in the study eye of 20/30 to 20/400 inclusive (snellen equivalents using the etdrs protocol at a distance of 4 meters). * in the opinion of the investigator, decreased vision in the study eye is due to foveal thickening from pscme and not to any other reason. exclusion criteria: * any patient who has other retinal diseases known to cause macular edema (choroidal neovascularization, vein occlusion, diabetic macular edema in the study eye). patients with nonexudative age related macular degeneration (armd) or non-proliferative diabetic retinopathy without macular edema can be included in the study. * other reason for decreased visual acuity (such as amblyopia, foveal atrophy, optic atrophy). * pre-existing diagnosis of glaucoma in the study eye * inability to comply with study or follow up procedures * pregnancy (women of child bearing age will be asked to take a urine pregnancy test prior to enrolling in the study).

Keywords: cystoid macular edema
effects of co-op approach on activity and participation of brazilian children with developmental coordination disorder

Conditions: Motor Skills Disorders; Attention Deficit and Disruptive Behavior Disorders

Summary: the purpose of this study is to investigate the effects of the cognitive orientation to daily daily occupational performance approach (co-op approach) on activity and participation in school-aged children with developmental coordination disorder (dcd).

children with difficulty performing activities that reflect negatively on participation can meet the criteria for developmental coordination disorder (dcd), which might impact their lives, leading to social isolation, depression and anxiety. several studies have examined the effectiveness of different intervention approaches, including process-oriented approaches that focus on enhancing body functions and structures to improve performance on functional tasks. although pediatric occupational therapists have traditionally used such approaches, evidence strongly suggests effectiveness for task-oriented interventions that focus on the performance of tasks that the child finds difficult to do. among these, co-op approach showed strong treatment effects. in co-op approach, therapists use mediational techniques to teach cognitive strategies to improve occupational performance in goals chosen by the children. there is a need to examine systematic intervention alternatives for brazilian children with dcd, and only one study examined occupational therapy intervention strategies for children with dcd. the main purpose of the study is to examine the effects of two intervention models based on co-op approach. the investigators will examine if a boosting on parent's engagement in co-op can improve skill acquisition, generalization and transfer in children with dcd. a pre-post design will be used and two groups will be included in this study (1) one receiving standard co-op approach, (2) one receiving standard co-op approach and an addition of coaching sessions in groups for parents. follow-up data will be collected 3 months later.

Eligibility criteria:
inclusion criteria: * score on mabc-2 below the 15th percentile; * score on dcdq-brazil below age expectation, indicating problems on everyday living and/or academic skills; * cognitive development within the expected age range according to the wechsler intelligence scale for children-fourth edition (wisc-iv); * no diagnosis or signs of neurological or neuromuscular diseases. exclusion criteria: * no reading ability; * child refuses to participate on assessment sessions.
optimization of nibs for diabetic neuropathy neuropathic pain

Conditions: Diabetic Neuropathies; Chronic Pain

Summary: the purpose of this study is to assess the effects of transcranial direct current stimulation (tdcs) in combination with transcranial ultrasound (tus) for the treatment of pain and functional limitations in subjects with diabetic neuropathic pain.

active stimulation will be compared with compared to sham stimulation in dnp patients. 20 dnp patients, 10 per group, receive stimulation or sham for 5 consecutive days, 20 min/day, followed by 2, 4, and 6 weeks post-therapy. 9 visits plus screening/baseline (total 10 visits). subsequently, 40 dnp patients will be enrolled, 20 per group, giving 5 consecutive days, 20 min/day, followed by 2 weeks of bi-weekly stimulation or sham for 20 min/day (total stimulations n=9) and follow-ups at 2, 4, 6, \& 8 weeks post-stim): 13 visits plus screening/ baseline (total 14 visits).

Eligibility criteria:
inclusion criteria: 1. able to provide informed consent to participate in the study. 2. subjects between 40 to 80 years old. 3. having diabetic neuropathic pain, involving at least 1 foot, with existing pain for at least 6 months, and having pain on at least half the days in the past 6 months with an average of at least a 4 on a 0-10 vas scale). 4. having pain resistant to common analgesics and medications for first-line therapy of chronic pain such as tylenol, aspirin, ibuprofen, soma, parafon forte dcs, zanaflex, codeine, etc. 5. must have the ability to feel pain as self-reported. exclusion criteria: 1. subject is pregnant. 2. contraindications to tdcs in conjunction with tus, i.e. metallic implant in the brain or implanted brain medical devices 3. history of alcohol or drug abuse within the past 6 months as self-reported. 4. use of carbamazepine within the past 6 months as self-reported. 5. suffering from severe depression (with a phq 9 score of ≥ 10). 6. history of neurological disorders as self-reported. 7. history of unexplained fainting spells as self-reported. 8. history of severe head injury resulting in more than a momentary loss of consciousness as self-reported. 9. history of neurosurgery as self-reported. 10. unstable pain (defined as pain intensities that vary by more than 4 points on 0-10 vas scale over the 1-week period of trial run-in).
biomarkers of pain and stress perception and dry needling technique application

Conditions: Low Back Pain

Summary: the use of the dry needling technique has become widespread in recent years for the treatment of musculoskeletal pain. although dry needling has been shown to be effective in the treatment of shoulder pain, elbow pain, headache, etc., we do not yet have a clear understanding of the mechanisms of action that justify its beneficial effects. in this study, we propose to analyse the biochemical markers of pain generated by the application of a dry needling technique on the lumbar musculature in patients with mechanical lumbar pain of non-specific origin. the aim of this study will be to evaluate the effects of dry needling technique on the plasmatic concentration of biochemical markers.furthermore, the test subjects will be randomly distributed into two groups. an experimental group where the subjects will receive a real dry needling technique. another group will be treated with a sham technique.


Eligibility criteria:
inclusion criteria: * mechanical lumbar pain of more than three months of evolution. exclusion criteria: * medical diagnosis of lumbar disc herniation or protrusion. * low back and leg pain. * pregnancy. * fibromyalgia. * fear of needles. * medication with anticoagulants

Keywords: low back pain dry needling biochemical markers
association of renal-tubular acidosis in children with cow milk protein allergy

Conditions: Cow's Milk Protein Allergy; Rta

Summary: our study aims to detect renal manifestations of children proved to be with cow milk protein allergy special focusing on tubular dysfunction.

this is a cross-sectional study that will be conducted over 6 months at the pediatric department, sohag university hospital, sohag, egypt. children proved to be with cow milk protein allergy by oral challenge test after stabilization and prevention of cow protein with age group from 3 months up to 3 years attending outpatient clinic at sohag university hospital will be included in the study. the study participants will be subjected to full history taking and thorough clinical examination at the pediatric outpatient clinic and their medical files will be reviewed.

Eligibility criteria:
inclusion criteria: * children proved to be with cow milk protein allergy by oral challenge test after stabilization and prevention of cow protein with age group from 3 months up to 3 years attending outpatient clinic at sohag university hospital will be included in the study exclusion criteria: -

Keywords: cmpa / rta